EUCTR2017-000469-62-ES进行中（未招募）1 期
Pilot single-arm clinical trial to evaluate the efficacy, PK interactions and safety of dolutegravir plus 2 NRTIs in HIV-1-infected solid organ transplant patients - DTG-SOT
Fundació Clínic per a la Recerca Biomèdica0 个研究点开始时间: 2017年6月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.HIV patients >18 years old who provide signed and dated informed consent;
- •2.Males and females;
- •3.SOT recipients (heart, liver or kidney);
- •4.On stable ART for =6 months preceding the screening visit;
- •5.Plasma HIV RNA <50 cop/ml for 12 months (2 tests separated by at least 12 months with no viral load >50 between determinations);
- •6.Absence of major reverse transcriptase or integrase gene mutations affecting study drug efficacy by proviral DNA sequencing
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.HIV patients who have stopped ART due to virological failure;
- •2.HIV patients who require treatment with DTG contraindicated medications;
- •3.History or presence of an allergy or intolerance to the study drug;
- •4.Active opportunistic infection;
- •5.Neoplasms requiring chemotherapy.
- •6.Pregnancy or breast feeding or planned pregnancy during the study period
- •7.Any other contraindication to study drugs.
研究者
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